MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL TRUFILL N-BCA-1 GRAM KIT; TISSUE ADHESIVE FOR USE IN EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS

Model Number 631-500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Nerve Damage (1979)

Event Date 12/13/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4) [ the event was reported via the membrane study.The 37-year-old male subject with a history of diabetes underwent a craniotomy of the right and frontal parietal side on (b)(6) 2022.The patient was randomized into the surgery + mma embolization cohort of the study.His baseline glasgow coma scale (gcs) score was 15, mini-mental state exam (mmse) score was 23, markwalder grading scale (mgs) score was 0 and modified rankin scale (mrs) score was 1.The hematoma thickness was 14 mm on the baseline ct scan.The patient underwent middle meningeal artery (mma) embolization of a right frontal and parietal subdural hematoma (sdh) on (b)(6) 2022.On (b)(6) 2022, the mma embolization study procedure was performed using right femoral access.The trufill n-bca 1x1 gram (631500 / m05f16) (3:1 oil: n-bca ratio) was delivered via an excelsior® sl-10® microcatheter (stryker) microcatheter.A cerebase guide sheath or envoy guide catheter (da or gc) was used during the procedure.The anterior and posterior branches and origin of the mma were embolized.Penetration without reaching the midline was performed as the embolization technique.No vasospasm occurred during the procedure.In the opinion of the treating physician, the embolization was successful.Non-target vessel embolization occurred during the procedure and resulted in cranial nerve vii palsy.The principal investigator assessed this event as moderate in severity, not serious, causally related to the study device and the (mma embolization) procedure (with n-bca), but not related to the chronic subdural hematoma (csdh) medication or to the surgical procedure to treat the csdh.This event was treated medically with methylprednisone and a heparin injection.The patient recovered and the event was resolved; the mini-mental state exam (mmse) score was 21, markwalder grading scale (mgs) score was 1, and modified rankin scale (mrs) score was 1.Based on complaint information, the device remains implanted and is thus not available for evaluation.A review of manufacturing documentation associated with this lot (m05f16) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.Product analysis cannot be conducted as the product was not returned for analysis.In addition, there was no report of malfunction associated with the device.As such, the investigation will be closed.The device performed as intended and no new patient consequences have occurred related to the use of the device.The assessment of the principal investigator, the event was causally related to the study device and the (mma embolization) procedure (with n-bca), but not related to the csdh medication or to the surgical procedure to treat the csdh.Therefore, this event meets mdr reporting criteria as a ¿serious injury.¿ the file will be re-reviewed if additional information is received at a later date.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Event Description

The event was reported via the membrane study.The 37-year-old male subject with a history of diabetes underwent a craniotomy of the right and frontal parietal side on (b)(6) 2022.The patient was randomized into the surgery + mma embolization cohort of the study.His baseline glasgow coma scale (gcs) score was 15, mini-mental state exam (mmse) score was 23, markwalder grading scale (mgs) score was 0 and modified rankin scale (mrs) score was 1.The hematoma thickness was 14 mm on the baseline ct scan.The patient underwent middle meningeal artery (mma) embolization of a right frontal and parietal subdural hematoma (sdh) on (b)(6) 2022.On (b)(6) 2022, the mma embolization study procedure was performed using right femoral access.The trufill n-bca 1x1 gram (631500 / m05f16) (3:1 oil: n-bca ratio) was delivered via an excelsior® sl-10® microcatheter (stryker) microcatheter.A cerebase guide sheath or envoy guide catheter (da or gc) was used during the procedure.The anterior and posterior branches and origin of the mma were embolized.Penetration without reaching the midline was performed as the embolization technique.No vasospasm occurred during the procedure.In the opinion of the treating physician, the embolization was successful.Non-target vessel embolization occurred during the procedure and resulted in cranial nerve vii palsy.The principal investigator assessed this event as moderate in severity, not serious, causally related to the study device and the (mma embolization) procedure (with n-bca), but not related to the chronic subdural hematoma (csdh) medication or to the surgical procedure to treat the csdh.This event was treated medically with methylprednisone and a heparin injection.The patient recovered and the event was resolved; the mini-mental state exam (mmse) score was 21, markwalder grading scale (mgs) score was 1, and and modified rankin scale (mrs) score was 1.

• Brand Name: TRUFILL N-BCA-1 GRAM KIT
• Type of Device: TISSUE ADHESIVE FOR USE IN EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 16107919
• MDR Text Key: 306783989
• Report Number: 3008114965-2023-00007
• Device Sequence Number: 1
• Product Code: KGG
• UDI-Device Identifier: 10886704029151
• UDI-Public: 10886704029151
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: 631-500
• Device Catalogue Number: 631500
• Device Lot Number: M05F16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EXCELSIOR® SL-10® MICROCATHETER (STRYKER).; UNKCEREBASE.; UNKENVOYDA.
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic